Good interobserver agreement was attainable on outcome adjudication in patients with stable coronary heart disease

Journal of Clinical Epidemiology

Volumn 65, Issue 4, 2012, Pages 444-453

  Kjoller, Erik ^a,c   Hilden, Jorgen ^b   Winkel, Per ^c   Frandsen, Niels J ^d   Galatius, Soren ^a   Jensen, Gorm ^e   Kastrup, Jens ^f   Hansen, Jorgen Fischer ^g   Kolmos, Hans J ^h   Jespersen, Christian M ^g   Hildebrandt, Per ⁱ   Gluud, Christian ^c  

^a GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c Mental Health Services CPH   (Denmark)

^d AMAGER HOSPITAL   (Denmark)

^e HVIDOVRE HOSPITAL   (Denmark)

^f Rigshospitalet   (Denmark)

^g BISPEBJERG HOSPITAL   (Denmark)

^h ODENSE UNIVERSITY HOSPITAL   (Denmark)

ⁱ FREDERIKSBERG HOSPITAL   (Denmark)

Author keywords

Clinical trial; End point; Myocardial infarction; Outcome assessment; Prognosis; Randomized controlled trial

Indexed keywords

CLARITHROMYCIN; PLACEBO;

ACUTE HEART INFARCTION; ANGINA PECTORIS; ARTICLE; CARDIOLOGIST; CHLAMYDIAL PNEUMONIA; DISEASE DURATION; ELECTROCARDIOGRAM; FATALITY; FOLLOW UP; HEART FAILURE; HEART INFARCTION; HUMAN; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MEDICAL RECORD; OBSERVER VARIATION; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); STABLE ANGINA PECTORIS; TREATMENT INDICATION; UNSTABLE ANGINA PECTORIS;

ALGORITHMS; ANTI-BACTERIAL AGENTS; CHLAMYDIA INFECTIONS; CHLAMYDOPHILA PNEUMONIAE; CLARITHROMYCIN; CONFIDENCE INTERVALS; CORONARY DISEASE; DENMARK; FOLLOW-UP STUDIES; HUMANS; INPATIENTS; MYOCARDIAL INFARCTION; OBSERVER VARIATION; PROGNOSIS; RISK ASSESSMENT; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 84857658195     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2011.09.011     Document Type: Article

References (27)

1. M.S. Lauer, and E.J. Topol Clinical trials - multiple treatments, multiple end points, and multiple lessons JAMA 289 2003 2575 2577 (Pubitemid 37430160)
2. U.S. Department of Health and Human Services - Food and Drug Administration. Guidance for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees. 2006:1-38. Available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf. Accessed November 13, 2011.
3. Committee for Medicinal Products for Human Use - European Medicines Agency (EMA). Guideline on Data Monitoring Committees. 2005:1-8. Available at http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500003635.pdf. Accessed November 13, 2011.
4. A. Dechartres, I. Boutron, C. Roy, and P. Ravaud Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal J Clin Epidemiol 62 2009 695 702
5. G. Parmar, P. Ghuge, J.H. Halanych, E. Funkhouser, and M.M. Safford Cardiovascular outcome ascertainment was similar using blinded and unblinded adjudicators in a national prospective study J Clin Epidemiol 63 2010 1159 1163
6. S. Hansen, B. Als-Nielsen, M. Damgaard, O.H. Helo, L. Petersen, and C.M. Jespersen Intervention with clarithromycin in patients with stable coronary heart disease: the CLARICOR trial design Heart Drug 1 2001 14 19 (Pubitemid 34701432)
7. C.M. Jespersen, B. Als-Nielsen, M. Damgaard, J.F. Hansen, S. Hansen, and O.H. Helo Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial BMJ 332 2006 22 27
8. C. Gluud, B. Als-Nielsen, M. Damgaard, H.J. Fischer, S. Hansen, and O.H. Helo Clarithromycin for 2 weeks for stable coronary heart disease: 6-year follow-up of the CLARICOR randomized trial and updated meta-analysis of antibiotics for coronary heart disease Cardiology 111 2008 280 287
9. Myocardial infarction redefined - a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction Eur Heart J 21 2000 1502 1513
10. Guidelines for the diagnosis of heart failure. The Task Force on Heart Failure of the European Society of Cardiology Eur Heart J 16 1995 741 751
11. A.H. Christensen, T. Gjorup, J. Hilden, C. Fenger, B. Henriksen, and M. Vyberg Observer homogeneity in the histologic diagnosis of Helicobacter pylori. Latent class analysis, kappa coefficient, and repeat frequency Scand J Gastroenterol 27 1992 933 939
12. J. Cohen A coefficient of agreement for nominal scales Educ Psychol Meas 20 1960 37 46
13. C.B. Granger, V. Vogel, S.R. Cummings, P. Held, F. Fiedorek, and M. Lawrence Do we need to adjudicate major clinical events? Clin Trials 5 2008 56 60 (Pubitemid 351412373)
14. J. Pogue, S.D. Walter, and S. Yusuf Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs Clin Trials 6 2009 239 251
15. S.D. Walter, D.J. Cook, G.H. Guyatt, D. King, and S. Troyan Outcome assessment for clinical trials: how many adjudicators do we need? Canadian Lung Oncology Group Control Clin Trials 18 1997 27 42 (Pubitemid 27145445)
16. K.W. Mahaffey, R.A. Harrington, M. Akkerhuis, N.S. Kleiman, L.G. Berdan, and B.S. Crenshaw Systematic adjudication of myocardial infarction end-points in an international clinical trial Curr Control Trials Cardiovasc Med 2 2001 180 186 (Pubitemid 32780805)
17. V.L. Serebruany The FDA prasugrel review: adjudication of myocardial infarction controversy Cardiology 114 2009 126 129
18. A. Heagerty, A. Deverly, C. Palmer, E. Kaplinsky, A. Salvetti, and N.G. Wahlgren The role of the critical event committee in a major cardiovascular outcome study Blood Press 11 2002 339 344 (Pubitemid 36061178)
19. U. Naslund, L. Grip, J. Fischer-Hansen, T. Gundersen, S. Lehto, and L. Wallentin The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial: results with and without the end-point committee's final decision on end-points Eur Heart J 20 1999 771 777 (Pubitemid 29209911)
20. N. Vejlstrup, P. Clemmensen, E. Steinmetz, K.N. Hansen, I. Christiansen, and P.R. Hansen Blinded end point adjudication in the Danish Multicenter Randomized Study on Fibrinolytic Therapy versus Acute Coronary Angioplasty in Acute Myocardial Infarction (DANAMI-2 trial) Heart 3 2003 127 133 (Pubitemid 37465124)
21. B.A. Kirwan, J. Lubsen, S. de Brouwer, N. Danchin, A. Battler, and A. Bayes de Luna Diagnostic criteria and adjudication process both determine published event-rates: the ACTION trial experience Contemp Clin Trials 28 2007 720 729 (Pubitemid 47505342)
22. K.W. Mahaffey, M.T. Roe, C.K. Dyke, L.K. Newby, N.S. Kleiman, and P. Connolly Misreporting of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Second Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network Trial Am Heart J 143 2002 242 248
23. K.W. Mahaffey, R.A. Harrington, M. Akkerhuis, N.S. Kleiman, L.G. Berdan, and B.S. Crenshaw Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study Curr Control Trials Cardiovasc Med 2 2001 187 194 (Pubitemid 32780806)
24. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. The EPIC Investigation N Engl J Med 330 1994 956 961
25. J.D. Curb, A. McTiernan, S.R. Heckbert, C. Kooperberg, J. Stanford, and M. Nevitt Outcomes ascertainment and adjudication methods in the Women's Health Initiative Ann Epidemiol 13 9 suppl 2003 S122 S128 (Pubitemid 37324181)
26. J.L. Petersen, G. Haque, A.S. Hellkamp, G.C. Flaker, E.N.A. Mark 3rd, and F.E. Marchlinski Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee Contemp Clin Trials 27 2006 260 268
27. L.P. McGarvey, M. John, J.A. Anderson, M. Zvarich, and R.A. Wise Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee Thorax 62 2007 411 415 (Pubitemid 46698390)